Multiple SclerosisNCT05627271
The 'Wearing Off' Effect of DMT
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ocrelizumab, natalizumab and ofatumumab
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2023to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with MS and clinicians with experience treating MS from Germany, UK, and US
Who may be able to join
- Patients who attend the following criteria will be included:
- Age ≥18;
- Current resident of the country of interest (i.e., Germany, the UK, or the US);
- Relapsing-remitting MS diagnosis confirmed by a clinician;
- Currently taking at least one of the following DMTs for MS after the maintenance phase: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®);
- Two or more consecutive ocrelizumab doses (Six or more consecutive natalizumab doses or Six or more consecutive ofatumumab doses);
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- Follow the approved dosing regimen (Ocrelizumab: every six months or Natalizumab: every month or Ofatumumab: every month);
- Experienced reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect);
- Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate;
- Able to read, understand, and communicate in English or German;
- Willing and able to participate in a phone/web-based (remote) one-on-one interview, and to be audio-recorded;
- Have an e-mail address and will have access to a computer or smartphone at the time of the interview to complete the electronic consent form.
- Clinicians who attend the following criteria will be included:
- Currently practices in one of the target countries (i.e., Germany, the UK, or the US);
- Is a licensed clinician with a specialty in neurology;
- Has prescribed at least one of the following DMTs within the last year: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®);
- Has treated at least 16 MS patients within the last month;
- Is personally responsible for treatment decisions for their patients;
- Has followed patients treating MS with any of the three DMTs for a. Two or more consecutive ocrelizumab doses or b. Six or more consecutive natalizumab doses. c. Six or more consecutive ofatumumab doses;
- Has treated patients who have experienced specific reoccurring symptoms towards the end of the dosing cycle (i.e., the wearing off effect);
- Willing and able to provide informed consent via a weblink, indicating they understand the study purpose and procedures and are willing to participate;
- Willing and able to participate in a phone/web-based interview, and to be audio-recorded.
- Able to read, understand, and communicate in English
Who cannot join
- Patients will be excluded from the enrollment if:
- Has a diagnosis of clinically isolated MS syndrome, primary progressive MS, or secondary progressive MS;
- Currently participates in an interventional MS clinical trial.
- Clinicians will be excluded from the enrollment if are currently involved as a key opinion leader or receives funding from one of the drug manufacturers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the 'Wearing Off' Effect From Disease-modifying Therapies (DMT) in Patients With Multiple Sclerosis: an Interview Based Study Among Patients and Clinicians
This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab
- Conditions
- Multiple Sclerosis
- Being tested
- ocrelizumab, natalizumab, ofatumumab
- Keywords
- Multiple Sclerosis, MS, ocrelizumab, Ocrevus, natalizumab, Tysabri, ofatumumab, Kesimpta, NIS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocrelizumabOther
Also called Ocrevus
Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.
natalizumabOther
Also called Tysabri
Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.
ofatumumabOther
Also called Kesimpta
Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.
| Study group | Role | What they receive |
|---|---|---|
| ocrelizumab | patients prescribed with ocrelizumab Receives: Other: ocrelizumab | |
| natalizumab | Patients prescribed with natalizumab Receives: Other: natalizumab | |
| ofatumumab | Patients prescribed with ofatumumab Receives: Other: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with key symptoms associated with the wearing off effect
Number of participants with the following recurring symptoms will be collected:
- Fatigue
- Physical Pain
- Mobility issues or walking difficulties
- Numbness or sensory issues
- Cognitive difficulties
- Weakness
- Spasms
- Balance disturbance or dizziness
- Blurry vision or visual impairment
- Others
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Secondary outcomes (5)
Severity of wearing off effect symptoms
Based on qualitative score rating
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Detailed language used to describe the experience of wearing off effect
Terms used to describe times when patients MS "gets better" and when it "gets worse" will be collected.
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Number of participants switching from one therapy to another due to wearing off effect
Number of participants switching from one therapy to another due to wearing off effect will be collected
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Number of participants who changed the dosing/infusion schedules due to wearing off effect
Number of participants who changed the dosing/infusion schedules due to wearing off effect will be collected
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Dissimilarities of clinician' and patients' views of wearing off effect
Assessed qualitatively via concept coding techniques
Measured: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start10 Jan 2023
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627271
- Sponsor's protocol ID
- COMB157G2012
- Status last verified
- May 2023
- First submitted
- 16 Nov 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the 'Wearing Off' Effect From Disease-modifying Therapies (DMT) in Patients With Multiple Sclerosis: an Interview Based Study Among Patients and Clinicians
- ClinicalTrials.gov ID
- NCT05627271
- Acronym / sponsor ID
- COMB157G2012
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, ocrelizumab, Ocrevus, natalizumab, Tysabri, ofatumumab, Kesimpta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed with MS and clinicians with experience treating MS will be interviewed regarding patient experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ocrelizumab | – | Other: ocrelizumabpatients prescribed with ocrelizumab |
| natalizumab | – | Other: natalizumabPatients prescribed with natalizumab |
| ofatumumab | – | Other: ofatumumabPatients prescribed with ofatumumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with MS and clinicians with experience treating MS from Germany, UK, and US
Key inclusion criteria (23 listed)
- Age ≥18;
- Current resident of the country of interest (i.e., Germany, the UK, or the US);
- Relapsing-remitting MS diagnosis confirmed by a clinician;
- Currently taking at least one of the following DMTs for MS after the maintenance phase: ocrelizumab (Ocrevus®), natalizumab (Tysabri®), or ofatumumab (Kesimpta®);
- Two or more consecutive ocrelizumab doses (Six or more consecutive natalizumab doses or Six or more consecutive ofatumumab doses);
Key exclusion criteria (4 listed)
- Has a diagnosis of clinically isolated MS syndrome, primary progressive MS, or secondary progressive MS;
- Currently participates in an interventional MS clinical trial.
- Clinicians will be excluded from the enrollment if are currently involved as a key opinion leader or receives funding from one of the drug manufacturers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ocrelizumabAlso: OcrevusNon-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. | Other | ocrelizumab |
| natalizumabAlso: TysabriNon-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. | Other | natalizumab |
| ofatumumabAlso: KesimptaNon-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study. | Other | ofatumumab |
Primary outcome
Number of participants with key symptoms associated with the wearing off effect
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Number of participants with the following recurring symptoms will be collected: * Fatigue * Physical Pain * Mobility issues or walking difficulties * Numbness or sensory issues * Cognitive difficulties * Weakness * Spasms * Balance disturbance or dizziness * Blurry vision or visual impairment * Others
5 secondary outcomes
Severity of wearing off effect symptoms
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Detailed language used to describe the experience of wearing off effect
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Number of participants switching from one therapy to another due to wearing off effect
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Number of participants who changed the dosing/infusion schedules due to wearing off effect
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Dissimilarities of clinician' and patients' views of wearing off effect
Time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with key symptoms associated with the wearing off effect (time frame: Assessed at the time of interview with lookback period from time of first MS diagnosis, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.